MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CROSSFIRE 10 DEG INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	2041C-3250
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reports she had a hip replacement including a 32mm v40 head implanted in 2012 and would like to know if her implants were subject to recall.Update 15-feb-2023: patient reported revision on (b)(6), 2022 due to instability, "knee popping" and difficulty walking.
Additional Manufacturer Narrative
Reported event: an event regarding instability involving an unknown metal head was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Patient called stating she had a hip replacement including a 32mm v40 head implanted in 2012.Patient would like to know if her implants were involved in a recall.As no device details was supplied then its not possible to determine if the patient¿s implant is subject to a recall.
Additional Manufacturer Narrative
Corrected data: device information, date of implant & explant, manufacturing site.An event regarding instability involving omnifit liner was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Patient called stating she had a hip replacement including a 32mm v40 head implanted in 2012.Patient would like to know if her implants were involved in a recall.It was determined that no recalls are associated with this device.The following devices were also listed in this report: secur-fit ha psl cup/clustr shell 50mm; cat# 2051-2050; lot# mkhhye.32mm std lfit v40 head; cat#6260-9-132 ; lot# 38356101.Accolade tmzf hip stem #5; cat# 6020-0537; lot# 31345501.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient reports she had a hip replacement including a 32mm v40 head implanted in 2012 and would like to know if her implants were subject to recall.Update 15-feb-2023: patient reported revision on (b)(6) 2022 due to instability, "knee popping" and difficulty walking.

• Brand Name: CROSSFIRE 10 DEG INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16535036
• Report Number: 0002249697-2023-00250
• Device Sequence Number: 17644221
• Product Code: LPH
• UDI-Device Identifier: 04546540035790
• UDI-Public: 04546540035790
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K974685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: 2041C-3250
• Device Catalogue Number: 2041C-3250
• Device Lot Number: 38368201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female